SBRT
Conditions
Keywords
SBRT, immunotherapy, oral cancer, oropharyngeal cancer
Brief summary
In resectable locally advanced oral cavity cancer and oropharyngeal cancer, SBRT with the total dose of 18 Gy by three fractions will be delivered to the primary tumor and metastatic lymph nodes every other day. One week later, neoadjuvant chemoimmunotherapy of Sindilizumab (200mg) plus docetaxel (75mg/m2) and cisplatin (75mg/m2) will be administered every three weeks for three cycles. Then radical surgical resection will be performed and postoperative radiotherapy with or without chemotherapy will be supplemented according to the initial tumor staging and postoperative pathologic characteristics. The investigators aim to evaluate the pathological complete response rate and safety of the combined treatment of SBRT with chemoimmunotherapy in locally advanced cancers of oral cavity and oropharynx.
Interventions
COMBINATION_PRODUCTSBRT+chemoimmunotherapy
All eligible patients will receive SBRT (6Gy\*3 fractions, qod) to the primary site and metastatic lymph nodes. One week later, neoadjuvant chemoimmunotherapy of Sindilizumab (200mg) plus docetaxel (75mg/m2) and cisplatin (75mg/m2) will be administered every three weeks for three cycles. Then radical surgical resection will be performed and postoperative radiotherapy with or without chemotherapy will be supplemented according to the initial tumor staging and postoperative pathologic characteristics.
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* pathologically confirmed squamous carcinoma of oral cavity or oropharynx * III-IVa based on the eighth edition of AJCC * aged 18 to 70 * ECOG PS 0-1 * no organ dysfunction * Expected survival ≥ 3 months
Exclusion criteria
* diagnosed with other malignant tumors * has autoimmune diseases or serious mental illness * at high risk of hemorrhage * Systemic or local glucocorticoid therapy within 4 weeks * Comorbidities requiring long-term treatment with immunosuppressive drugs or systemic or topical corticosteroids in immunosuppressive doses * Patients with active tuberculosis (TB) who are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year prior to screening. * Prior use of anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, or anti-CTLA-4 antibody * HIV or HCV * HBsAg positive with positive HBV DNA copy number (quantitative test) ≥1000cps/ml
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| rate of pathological complete response | immediately after the surgery | pathological complete response rate after radical resection |
Secondary
| Measure | Time frame |
|---|---|
| rate of major pathological response | immediately after the surgery |
| objective response rate | two weeks after the chemoimmunotherapy |
| disease free survival | 3-year |
| overall survival | 3-year |
| rate of adverse events | one month after the postoperative radiotherapy |
Countries
China
Contacts
Primary ContactFang-Yun Xie
Backup ContactXue-Kui Liu
Outcome results
None listed